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Aclaris Therapeutics, Inc. (Nasdaq: ACRS) announced that it has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for its drug candidate ATI-50001 for the treatment of alopecia universalis and alopecia totalis. Aclaris plans to conduct a human pharmacokinetic/pharmacodynamic (pK/pD) study to evaluate the safety of ATI-50001 in healthy volunteers.

“We are excited to have achieved this important milestone,” said Dr. Stuart Shanler, Chief Scientific Officer. “We look forward to developing ATI-50001 as a potential oral treatment for these severe phenotypes of alopecia areata.”

Alopecia areata is an autoimmune disease characterized by patchy, non-scarring hair loss on the scalp and body. The scalp is the most commonly affected area, and the National Alopecia Areata Foundation estimates that 6.8 million patients in the United States have had or will develop alopecia areata during their lives.1 The disease affects both women and men; two-thirds of affected individuals are younger than 30 years old at the time of onset of disease. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression.2 A significant unmet need exists for a safe and efficacious treatment.

Aclaris has exclusively licensed several patents and patent applications involving novel selective Janus kinase (JAK) 1/3 inhibitors, including a patent portfolio from Rigel Pharmaceuticals, Inc. that covers ATI-50001 as well as ATI-50002, a topical formulation also being developed as a potential treatment for alopecia areata. In addition, Aclaris has exclusively licensed a patent portfolio from JAKPharm and Key Organics directed to novel covalently binding, highly selective JAK 3 inhibitors. Finally, Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, androgenetic alopecia, and other dermatological conditions. This portfolio includes a recently issued U.S. patent directed to methods of treating alopecia areata, androgenetic alopecia and other hair loss disorders by administering ruxolitinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating alopecia areata, androgenetic alopecia and other hair loss disorders.